FDA regulates foods and food ingredients sold in the USA, with the exception of meat, poultry, and certain processed egg products regulated by the U.S. Department of Agriculture (USDA).
Food facility registration is one of the FDA requirements for food products.
If you are a foreign company or importing food products manufactured in foreign country, then such foreign facilities are required to appoint U.S Agent and register the facility. Pragmatic Compliance LLC shall act as U.S Agent for food facility registration purpose and register the facility. Our fee for food facility registration including one-year U.S Agent services is $ 299.
You can complete our online food facility registration form below link and make the payment. It will take less than two working days to obtain a food facility registration number.
If you are domestic food manufacturing, processing, packing or warehouse facility, you are required to register with FDA. Our fee for domestic food facility registration is $ 149. Please contact us for the offline form.
Please note, FDA does not issue the food facility certificate and the certificate is not required. You will get the food facility registration number from the FDA through email. Our company can issue the food facility registration certificate for your reference.
Product labeling is one of the most important FDA requirements for food products.
Labeling is one of the important FDA requirements for food products. We can offer labeling review services and our fee for per product labeling review is $ 299. In order to review the label, you should provide us label design in PDF or image format.
We offer discounts on multiple labeling reviews.
Failure to comply with labeling requirements may result in a misbranded product and detention action.
Before shipping goods, you must notify FDA about the arrival of your shipments well in advance by submitting prior import notice.
If you wish to file prior import notice yourself, we can send you the step by step instruction which you can follow and submit the prior import notice. If you want us to submit prior import notice, then our fee per shipment prior notice filing is $ 15.
The foreign manufacturer is required to identify the importer for FSMA compliance purposes. If you are an importer or already have an importer in the United States, such an importer is responsible for supplier verification responsibilities.
Pragmatic compliance can act as an FSVP importer for foreign companies, the fee for FSVP Agent services depends on the Product and projected annual sales in terms of USD.
The foreign manufacturer has to go through our supplier evaluation process and we may require several product quality and safety-related documents in order to act as FSVP Agent. Please contact us for more information.
GMP and HAACP are most important FDA requirements for food manufacturers.
In order to food and dietary supplements in the United States companies should follow GMP and maintain proper documentation. After the facility is registered you can start shipping the products however FDA may inspect the food facility for food safety or GMP compliance verification.
All commercial processors of low-acid and acidified foods located in the United States and all processors in other countries who export low-acid canned food or acidified food products into the United States must register their processing plants with FDA. Wholesalers, importers, distributors, brokers, etc. are not required to register and file processes. However, they must ensure that processing firms they represent comply with all registration and process filing requirements.
Here is the list of some important FDA regulations for foods. A complete list of FDA regulations for food can be found in the 21 CFR SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION
General 21 CFR Part 100
Food labeling regulations 21 CFR Part 101
Foods for special dietary use 21 CFR Part 105
Good manufacturing practice (GMP) 21 CFR Part 110
GMP for dietary supplements 21 CFT Part 111
Hazard analysis and critical control points (HACCP) 21 CFR Part 120
Dietary Supplements 21 CFR Part 190
Note: – If you are low acid or canned food manufacturer please contact us for more information.